Endo provides more info on oxymorphone ER and IR tablets
Endo Pharmaceuticals has responded to the FDA's request for more information on the company's application for the investigational painkillers oxymorphone extended-release (ER) and immediate-release (IR) tablets. The FDA requested additional clinical trials to further confirm the safety and efficacy of the products after issuing approval letters in October 2003. If its product is approved, Endo said it's prepared to launch oxymorphone in the second half of 2006.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
